Cognitive Groove (Brought to You by GERAS DANCE) (GERAS DANCE)

June 27, 2025 updated by: Alexandra Papaioannou, McMaster University

Does Cognitive Groove (Brought to You by GERAS DANCE) Improve Physical Performance in Community-Dwelling Older Adults With Frailty: A Parallel Randomized Controlled Trial

The goal of this clinical trial is to determine the effect of a community-based rehabilitation intervention (Cognitive Groove, Brought to you by GERAS DANCE), compared to usual care, on clinical outcomes in community-dwelling older adults living with frailty. The main questions it aims to answer are:

  1. In community-dwelling older adults living with frailty, is Cognitive Groove more effective than usual care in improving functional movement, physical performance and strength?
  2. In community-dwelling older adults living with frailty is Cognitive Groove more effective than usual care in improving frailty status, fear of falling, balance confidence, mood, cognition, grip strength, activities of daily living, life space mobility, loneliness, and quality of life?
  3. As a community-based rehabilitation intervention, is Cognitive Groove a cost-effective intervention embedded within the community for older adults living with frailty after 12-months?

Participants will participate in Cognitive Groove classes twice per week for 3 months or receive no intervention (usual care).

Study Overview

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Patricia Hewston, PhD
  • Phone Number: 74161 905-521-2100
  • Email: hewstonp@hhsc.ca

Study Locations

    • Ontario
      • Hamilton, Ontario, Canada, L8M 1W9
        • Recruiting
        • Geras Centre for Aging Research, St. Peter's Hospital, Hamilton Health Sciences
        • Contact:
          • Patricia Hewston, PhD
          • Phone Number: 74161 905-521-2100
          • Email: hewstonp@hhsc.ca
        • Principal Investigator:
          • Alexandra Papaioannou, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Community-dwelling aged ≥65 years
  • At high risk for mobility disability/functional limitations as assessed by the FRAIL Scale ≥2
  • Able to ambulate independently (25 m) with or without an assistive device
  • Able to follow two-step instructions
  • Medical clearance from referring clinician, or for self-referrals, medical clearance from family physician to safely participate in exercise
  • Can arrange transportation to the YMCA up to 2 times per week

Exclusion Criteria:

  • Unable to speak or understand English
  • Current regular participation in a structured exercise program or receiving active physical therapy services
  • Severe cardiac or pulmonary disease
  • Unstable angina or heart failure
  • Severe osteoarthritis (e.g., awaiting joint replacement)
  • Parkinson's disease or other progressive neurological disorder
  • Receiving palliative care
  • Travel/commitments requiring missing more than two weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Groove (GERAS DANCE)
Classes will occur twice per week for 3 months. Classes follow a consistent sequence of activities (orientation and socialization [10-mins]; warm-up [5-mins]; structured dance [30-mins]; cool-down [5-mins]; socialization and review of weekly hand-outs for balance exercises [10-mins]. The curriculum schedule includes five foundations and seven routines. Cognitive Groove (GERAS DANCE) foundations emphasize learning the ABCs of movement and increasing participants' confidence to move their bodies forward and backward and side-to-side with improved speed and rhythmicity. Cognitive Groove (GERAS DANCE) routines combine the foundational skills into full choreographed dances to music from the '50s and '60s (e.g., rock and roll, jazz, salsa, cha cha cha, rhythm soul, swing, disco, and Bollywood). Participants will receive an intervention-specific study manual that describes the homework exercises for each week.
Cognitive Groove (GERAS DANCE) presents a novel approach to increasing or maintaining independence and quality of life by improving physical performance and mobility using reminiscent music and rhythmic movement in a fun, safe environment. Cognitive Groove was designed to meet the complex needs of older adults with frailty. Our pilot quasi-experimental studies have demonstrated Cognitive Groove results in clinically significant improvements in walking speed by 0.1 m/s with enhanced temporal-spatial walking parameters and improved lower extremity function, including balance and chair stands.
Other Names:
  • Cognitive Groove (GERAS DANCE)
No Intervention: Usual Care
The control arm participants will continue with their usual care and normal activities. They will not receive any intervention during the study but will be given the opportunity to participate in Cognitive Groove (GERAS DANCE) programming after the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Physical Performance
Time Frame: Baseline and 3-months
Physical function will be assessed with the Short Performance Physical Battery [total score]. Higher scores indicate better physical performance [range 0-12].
Baseline and 3-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Walking Speed
Time Frame: Baseline and 3-months
Walking speed will be assessed with the 400-m Walk Test [walking speed, m/s]. Faster walking speeds indicate better performance.
Baseline and 3-months
Change in Functional Mobility
Time Frame: Baseline and 3-months
Functional mobility will be assessed with the Timed Up and Go (TUG) Test [total time, s]. A higher score indicates a greater falls risk (greater or equal to 12 sec) and lower functional mobility.
Baseline and 3-months
Change in Dual Task Ability
Time Frame: Baseline and 3-months
Dual-task ability will be assessed by the TUG-Cognitive (Dual Task Ability) [total time, s]. Higher time indicates worse performance.
Baseline and 3-months
Change in Static Postural Control
Time Frame: Baseline and 3-months
Static postural control will be assessed by the Single Leg Stance Test [total time, s]. Higher scores indicate better postural control.
Baseline and 3-months
Change in Hand Grip Strength
Time Frame: Baseline and 3-months
Hand grip strength will be assessed with a handgrip dynamometer [kg]. Higher measures indicate higher grip strength.
Baseline and 3-months
Change in Cognition
Time Frame: Baseline and 3-months
Cognition will be assessed with the Montreal Cognitive Assessment [total score]. Higher scores indicate better cognition [range 0-30].
Baseline and 3-months
Change in Cognition
Time Frame: Baseline and 3-months
Change in cognition will be assessed using the Trail Making Test (TMT) [total time, s]. Higher time indicates worse performance.
Baseline and 3-months
Change in Cognition
Time Frame: Baseline and 3-months
Cognition will be assessed using the Digit Symbol Substitution Test (DSST) [total score]. Higher scores indicate better cognition [range 0-100].
Baseline and 3-months
Change in Frailty
Time Frame: Baseline and 3-months
Frailty will be assessed with the Fit-Frailty Index [total score]. Higher scores indicate greater frailty [range 0-1].
Baseline and 3-months
Change in Fear of Falling
Time Frame: Baseline and 3-months
Fear of falling will be assessed by the Falls Efficacy Scale International (FES-I) [total score]. Higher scores indicate greater fear of falling [range 16-64].
Baseline and 3-months
Change in Balance Confidence
Time Frame: Baseline and 3-months
Balance confidence will be assessed by the Activities-specific Balance Confidence (ABC) Scale [total score]. Higher scores indicate higher confidence [range 0-100].
Baseline and 3-months
Change in Depression/Mood
Time Frame: Baseline and 3-months
Depression and mood will be assessed with the Patient Health Questionnaire-9 (PHQ-9) [total score]. Higher scores indicate more depressive symptoms [range 0-27].
Baseline and 3-months
Change in Loneliness
Time Frame: Baseline and 3-months
Loneliness will be assessed by the University of California Los Angeles (UCLA) Loneliness Scale [total score]. Higher scores in indicate higher loneliness [range 20-80].
Baseline and 3-months
Change in Basic Activities of Daily Living
Time Frame: Baseline and 3-months
Activities of daily living will be assessed with the Katz activities of daily living questionnaire [total score]. Lower scores indicate greater impairment [range 0-6].
Baseline and 3-months
Change in Instrumental Activities of Daily Living
Time Frame: Baseline and 3-months
Activities of daily living will be assessed with Lawton instrumental activities of daily living questionnaire [total scores]. Lower scores indicate greater impairment [range 0-8].
Baseline and 3-months
Change in Life Space Mobility
Time Frame: Baseline and 3-months
Life space mobility will be assessed with the Life Space Assessment [total score]. Higher scores indicate a larger life space [range 0-120].
Baseline and 3-months
Change in Health-related Quality of Life
Time Frame: Baseline, 3-months, and 12-months
Health-related quality of life will be assessed using the Health Utilities Index (HUI). Higher scores indicate better health-related quality of life [range 0-1].
Baseline, 3-months, and 12-months
Change in Healthcare Utilization
Time Frame: Baseline, 3-months, and 12-months
Number of emergency room visits and hospitalizations will be recorded. Higher number of visits indicates higher healthcare utilization.
Baseline, 3-months, and 12-months
Change in Healthcare Utilization
Time Frame: Baseline, 3-months, and 12-months
Healthcare services use will be recorded. Higher number of visits, medications, etc., indicates higher healthcare utilization.
Baseline, 3-months, and 12-months
Change in Falls
Time Frame: Baseline to 3-months
Number of falls will be assessed by self-report and electronic health record.
Baseline to 3-months
Change in Falls-Related Injuries
Time Frame: Baseline to 3-months
Number of falls-related injuries will be assessed by self-report and electronic health record.
Baseline to 3-months
Change in Mobility
Time Frame: Baseline to 3-months
Change in mobility will be assessed by the total number of steps taken daily (e.g., Actigraph accelerometer). Higher number of steps indicates greater mobility.
Baseline to 3-months
Adherence
Time Frame: Baseline to 3-months
Class attendance and homework completion will be recorded [total number completed]. Higher class attendance and homework completion indicates greater adherence.
Baseline to 3-months
Change in Walking Speed
Time Frame: Baseline to 3-months
Change in walking speed will be assessed by 8-ft walking speed [m/s]. Faster walking speeds indicate better performance.
Baseline to 3-months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual-level Economic Evaluation
Time Frame: Baseline, 3-months, and 12-months
Individual-level economic evaluations will be assessed by changes in direct medical costs and effectiveness outcomes (e.g., quality-adjusted life years - QALYs), calculate and compare the incremental cost-effectiveness ratio (ICER) (e.g., $/ QALY gained, $/ a visit averted) against a willingness-to-pay threshold ($50,000/QALY) to show if this program represents good value for money.
Baseline, 3-months, and 12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alexandra Papaioannou, MD, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Estimated)

July 1, 2025

Last Update Submitted That Met QC Criteria

June 27, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18231

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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